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Hormone Therapy

IV Oxytocin for Pain

Phase 2
Recruiting
Led By James C Eisenach, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female > 18 and < 75 years of age, Body Mass Index (BMI) <40
For knee arthritis subjects, normal blood pressure or, for those with hypertension, pressure controlled with anti-hypertensives and with a resting heart rate 45-100 beats per minute
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 180 minutes after baseline
Awards & highlights

Study Summary

This trial investigates how oxytocin affects pain when administered through IV and how long the effects last.

Who is the study for?
This trial is for adults aged 18-75 with a BMI under 40, in good health or controlled hypertension, and not on daily pain medications. Women of childbearing age must use effective birth control. It excludes those with allergies to Pitocin®, chronic conditions that increase risk, pregnant/nursing women, individuals with certain heart issues or neuropathy, and those at risk for hyponatremia.Check my eligibility
What is being tested?
The study tests how oxytocin given through an IV affects the perception of heat pain on the skin. Participants will rate their pain during intervals before, during, and after receiving oxytocin to help create models predicting its analgesic effects.See study design
What are the potential side effects?
While specific side effects are not listed for this trial's intervention (oxytocin), common reactions may include nausea, headache, changes in blood pressure or heart rate; allergic reactions are possible but considered exclusionary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 75 years old with a BMI under 40.
Select...
I have knee arthritis with normal blood pressure or controlled hypertension and my resting heart rate is between 45-100 bpm.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~180 minutes after baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and 180 minutes after baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pain during sustained heat

Trial Design

1Treatment groups
Experimental Treatment
Group I: Intravenous OxytocinExperimental Treatment1 Intervention
Two 30 minute infusion of oxytocin, 17 micrograms with will be administered. The second infusion will be given 30 minutes after the completion of the first infusion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxytocin
2016
Completed Phase 4
~2340

Find a Location

Who is running the clinical trial?

National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,341 Previous Clinical Trials
649,565 Total Patients Enrolled
12 Trials studying Chronic Pain
1,655 Patients Enrolled for Chronic Pain
Wake Forest University Health SciencesLead Sponsor
1,243 Previous Clinical Trials
1,004,706 Total Patients Enrolled
13 Trials studying Chronic Pain
734 Patients Enrolled for Chronic Pain
James C Eisenach, MDPrincipal InvestigatorWake Forest University Health Sciences
17 Previous Clinical Trials
811 Total Patients Enrolled
4 Trials studying Chronic Pain
100 Patients Enrolled for Chronic Pain

Media Library

Oxytocin (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05929339 — Phase 2
Chronic Pain Research Study Groups: Intravenous Oxytocin
Chronic Pain Clinical Trial 2023: Oxytocin Highlights & Side Effects. Trial Name: NCT05929339 — Phase 2
Oxytocin (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05929339 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this medical experiment accept participants aged 18 and over?

"This study is seeking out individuals aged 18 to 75. Meanwhile, there are 113 trials available for minors and 823 studies targeting elderly patients."

Answered by AI

Is there a specific demographic that is eligible to enroll in this trial?

"This clinical trial seeks 24 volunteers who suffer from chronic pain and age between 18-75. Accordingly, any individual that satisfies these two criteria may submit an application for consideration."

Answered by AI

Are participants being actively enrolled in this research project?

"Clinicaltrials.gov's data indicates that this clinical trial is no longer enrolling participants, despite having been posted on the 8th of August in 2023 and recently revised on June 23rd. Nevertheless, at present there are 1,306 other studies across the world recruiting patients."

Answered by AI

What potential risks are associated with Intravenous Oxytocin administration?

"As Intravenous Oxytocin is currently being trialled in Phase 2, our team has graded its safety as a two due to the moderate amount of evidence attesting to its security but lack thereof concerning efficacy."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Defining a PK and PD Model for Peripheral Analgesia After IV Oxytocin
2023. "Defining a PK and PD Model for Peripheral Analgesia After IV Oxytocin". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05929339.
All > Acute Pain > Oxytocin
~11 spots leftby Dec 2024
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